throbber
Catheterization and Cardiovascular Interventions 76:102–111 (2010)
`
`Distal Stent Delivery With Guideliner Catheter:
`First in Man Experience
`
`PhD, BM BCh, Farzin Fath-Ordoubadi,1
`Mamas A. Mamas,1,2
`and Douglas G. Fraser,1* MD, BM BChir
`
`MD, BM BChir,
`
`Failure to deliver stents is one of the commonest causes of procedural failure in contem-
`porary PCI practice. We describe successful use of the Guideliner Catheter, the first pur-
`pose designed FDA and CE marked device delivery catheter in 13 complex cases in
`native coronary vessels and bypass grafts performed via the radial route to enable distal
`stent delivery following failure of conventional techniques. We discuss how the Guide-
`liner catheter may be used to facilitate difficult radial cases.
`VC 2010 Wiley-Liss, Inc.
`
`Key words: TRAD; transradial cath; PCI; percutaneous coronary intervention; ANGO;
`angiography; coronary
`
`INTRODUCTION
`
`Failure to deliver stents during percutaneous coronary
`interventions (PCI) is one of the major causes of proce-
`dural failure that may occur in up to 5% of cases in con-
`temporary PCI practice [1,2]. We have previously
`described use of the Terumo 5F Heartrail II catheter
`within a standard 6F guiding catheter (so called ‘‘five-in-
`six’’ system) to aid stent delivery. Extra deep coronary
`intubation using this catheter increases backup support
`and bypasses proximal points of obstruction to enable
`distal stent delivery in both native coronary vessels and
`coronary artery bypass grafts [3,4].
`The Terumo ‘‘five-in-six’’ Heartrail II system was
`developed for use in chronic total occlusion PCI cases
`in order to increase back-up support [5]. Conversely,
`the Guideliner catheter (Vascular Solutions, MN) that
`has now been both CE marked and FDA approved has
`been developed more specifically with device delivery
`in mind. The Guideliner ‘‘five-in-six’’ catheter (Vascu-
`lar Solutions, MN) is essentially a rapid exchange or
`monorail equivalent of the ‘‘five-in-six’’ Heartrail II
`catheter that consists of a short guide catheter exten-
`sion connected to an introducer rod, and so is poten-
`tially easier to use than the Heartrail II catheter. In this
`case series we describe our initial experience with the
`use of this catheter for stent delivery and backup sup-
`port in a series of challenging cases performed transra-
`dially, and discuss its potential utility in complex radial
`PCI cases.
`
`METHOD OF INTRODUCTION
`
`connected via a metal collar to a 115 cm stainless steel
`shaft to a proximal positioning tab (Fig. 1A). At any
`time, following placement of the mother guide catheter
`and coronary wire in the target vessel,
`the 20 cm
`Guideliner catheter can be advanced over the wire
`through the haemostatic valve without the need to dis-
`connect this from the mother guide. The catheter tip is
`then advanced beyond the tip of the mother guide into
`the coronary vessel by pushing on the proximal tab.
`The interventional procedure is performed in the usual
`manner through the haemostatic valve (Fig. 1B and C).
`Frequently, placement would follow predilation of the
`target vessel and prior attempts at stent placement.
`Conversely, introduction of the much longer 120 cm
`Heartrail II catheter requires removal of the haemo-
`static valve followed by advancement over the coro-
`nary wire into and through the mother guide, with sub-
`sequent reconnection of the haemostatic valve to the
`proximal end of the Heartrail catheter [3,4,6]. Again,
`
`1Manchester Heart Centre, Manchester Royal Infirmary, Bio-
`medical Research Centre, Manchester, United Kingdom
`2Manchester Academic Health Science Centre, University of
`Manchester, Manchester, United Kingdom
`
`Conflict of interest: Nothing to report.
`
`*Correspondence to: Dr. Douglas G. Fraser, Manchester Heart Centre,
`Manchester Royal Infirmary, Biomedical Research Centre, Manchester,
`M13 9WL, United Kingdom. E-mail: Douglas.Fraser@cmft.nhs.uk
`
`Received 3 December 2009; Revision accepted 5 January 2010
`
`The 5-in-6 Guideliner catheter is a 20 cm soft tipped
`00
`5F catheter with an internal diameter (ID) of 0.056
`
`DOI 10.1002/ccd.22458
`Published online 8 April 2010 in Wiley InterScience (www.
`interscience.wiley.com)
`
`VC 2010 Wiley-Liss, Inc.
`
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`Stent Delivery Guideliner Catheter
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`103
`
`Fig. 1. A: The 6Fr Guideliner catheter is a 20 cm soft tipped
`catheter (Arrow 4) connected via a metal collar (Arrow 3) to a
`115 cm stainless steel shaft (Arrow 2) with a large proximal
`tab (Arrow 1) for accurate positioning of the device within the
`coronary system. B: Guideliner catheter setup. The Guideliner
`is passed through the haemostatic valve over a guidewire.
`
`The proximal tab (Arrow 1) is attached to the 115 cm stainless
`steel shaft that attaches to the 20 cm soft tipped catheter
`(Arrow 2) seen to extend from the guide catheter (Arrow 3).
`The proximal tab can be used to position the 20 cm soft tip
`catheter more distally into the vessel (C).
`
`this is frequently performed following predilation and
`prior attempts at stent placement. When complete re-
`moval of the Heartrail catheter is required, the haemo-
`static valve needs to be removed and reconnected to
`the mother guide, and may dislodge the coronary wires
`if these are not docked. Conversely, removal of the
`Guideliner catheter can be performed without reposi-
`tioning of the haemostatic valve or docking the wires
`in a similar fashion to removal of a monorail balloon.
`Consequently, advancement, positioning, and removal
`of the Guideliner catheter is potentially greatly simpli-
`fied in comparison to the Heartrail catheter.
`
`Case 1
`
`A 48-year-old female with significant exertional an-
`gina and good left ventricular
`function underwent
`attempted recanalisaton of a chronically occluded LAD
`artery (Fig. 2A). Access was from the right radial ar-
`tery with a 6F Cordis extra backup guiding catheter.
`Wire crossing was rapidly achieved using a whisper
`wire to negotiate a visible microchannel connecting the
`proximal and distal lumens (Fig. 2B). However, subse-
`quent passage of either a Finecross microcatheter or a
`low profile 1.25-mm balloon (Riujn, Terumo) was
`unsuccessful due to marked resistance at the entry to
`the microchannel. A Guideliner catheter was therefore
`introduced over the coronary wire, through the guiding
`catheter. This was advanced 4 cm beyond the tip of
`
`the guide catheter into the LAD, up to the point of
`occlusion. Subsequent passage of a Quickcross micro-
`catheter across the occlusion was achieved (Fig. 2C),
`and the Whisper wire was exchanged for a super sup-
`port Mailman wire. Subsequent introduction of a 1.25
`mm balloon allowed expansion of the microchannel,
`with successful
`further balloon dilation and finally
`
`stenting using a 2.5  38 mm Xience (Fig. 2D) and 3
` 28 mm Promus stents. These stents were further
`
`expanded with 2.75 and 3 mm balloons to high pres-
`sure with an excellent angiographic result (Fig. 2E).
`
`Case 2
`
`A 79-year-old lady with good resting left ventricular
`function was admitted with an NSTEMI associated
`with critical single vessel disease of a large RCA. The
`RCA was heavily calcified with 95% stenoses of the
`mid vessel and distal vessel at the crux extending into
`PDA and PLV branches with TIMI 2 flow (Fig. 3A).
`Access was from the right radial artery using a JR4
`guiding catheter. Two Choice floppy wires (Boston
`Scientific) were advanced into the PDA and PLV
`branches respectively and both lesions were predilated
`with 2.5-mm compliant and 3-mm angiosculpt balloons
`(Pyromed). However, stent delivery across the proxi-
`mal lesion was not possible due to significant calcifica-
`tion and resistance to stent passage hence a Guideliner
`catheter was advanced into the RCA. To aid deep
`
`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
`Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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`104
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`Mamas et al.
`
`Fig. 2. Chronically occluded LAD (A) and subsequent crossing of the lesion with whisper
`wire (B). (C) illustrates positioning of the Guideliner catheter into the LAD (second vertical
`arrow) and the position of the guide catheter is shown by the first arrow. The horizontal
`arrow illustrates the Quickcross microcatheter used to exchange the whisper wire for a more
`supportive mailman wire. (D) positioning of xience stent and final result (E).
`
`the catheter a 2.5-mm balloon was
`intubation of
`inflated in the distal RCA lesion and a combination of
`gentle traction on inflated balloon and push on the
`Guideliner catheter allowed passage of the Guideliner
`
`beyond the midvessel lesion. A 4  23-cm Biomatrix
`
`stent was then advanced without resistance through the
`midvessel lesion within the Guideliner catheter and on
`into the distal vessel (Fig. 3B). The Guideliner was
`then brought back into the proximal vessel and the
`stent was brought back into the mid vessel stenosis
`were it was inflated with good strut expansion. Again,
`
`lesion as an
`using an inflated balloon in the distal
`anchor,
`the Guideliner was advanced through the
`deployed stent into the distal vessel. A Triton bifurca-
`tion stent was then advanced to the distal vessel
`through the Guideliner catheter and was deployed
`across the crux into the PLV branch. Further stents
`were then placed in the PLV branch distal to the crux
`and from the distal RCA into the PDA. A final kissing
`balloon from the distal RCA into the PDA and PLV
`branches completed the procedure with an excellent
`angiographic result.
`
`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
`Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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`Stent Delivery Guideliner Catheter
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`105
`
`Fig. 3. A: RCA at start of case. B: Guideliner catheter (Horizontal arrow) used to bypass
`proximal point of obstruction enabling delivery of biomatrix stent (Vertical arrow). The guide
`catheter is illustrated by vertical arrow at top of figure. C: opacification of RCA following
`stenting of proximal and mid RCA. D: Triton bifurcation stent (Vertical arrow) delivered into
`PLV branch of RCA through Guideliner catheter (Horizontal arrow) passed through previously
`deployed proximal stents. E: Final result.
`
`Case 3
`
`A 76-year-old male with good left ventricular func-
`tion and previous CABG was scheduled for PCI of the
`native RCA due to ongoing ischaemia at rest in this
`territory that had no graft supply. The RCA was dif-
`fusely diseased from the proximal to the distal vessel
`with heavy calcification, marked tortuousity and subto-
`tal occlusion of the midvessel (Fig. 4A). We proceeded
`from the right radial artery using a 6F JR4 catheter and
`
`successfully crossed into the distal vessel using a
`Whisper wire. The mid and proximal RCA was dilated
`with 1.5, 2.5, and 2.75 mm balloons (Maverick, Bos-
`ton), however stent passage was unsuccessful due to
`heavy calcification and tortuosity. The Guideliner cath-
`eter was then advanced 3.5 cm into the proximal RCA,
`enabling deployment of a 2.5 by 18 mm Promus stent
`to the site of subtotal occlusion in the mid RCA
`(Fig. 4B). Again with the aid of deep intubation an
`
`overlapping 3  28 mm Promus stent could then
`
`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
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`Mamas et al.
`
`Fig. 4. A: Angiographic appearance of RCA at start of case. B: Positioning of initial Promus
`stent (Horizontal arrow). The Guideliner catheter and guide catheter are shown by vertical
`arrows. C: Passage of Guideliner catheter through the proximally deployed stents and opaci-
`fication of the distal vessel demonstrating further disease. Distal end of Guideliner high-
`lighted by horizontal arrow. D: Final result.
`
`to
`placed proximally extending from the first stent
`the proximal RCA. This allowed visualization of the
`distal RCA that had two further severe stenoses to-
`gether with a severe stenosis of the proximal PDA.
`To treat these lesions a 2.5-mm balloon was inflated
`in the distal RCA and the Guideliner catheter
`advanced through the stented segments into the dis-
`tal RCA (Fig. 4C). Following predilation this
`
`allowed easy passage of a 2.25  23 mm Promus
`a further 3  28 mm Promus stent that overlapped
`
`stent that extended from the RCA into the PLV and
`
`this stent and the first stent placed. Following post
`dilation of the RCA stents to 3 mm and stenting of
`
`the proximal RCA with two 3.5  8 mm Promus
`
`stents, an excellent angiographic result was achieved
`(Fig. 4D).
`
`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
`Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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`Stent Delivery Guideliner Catheter
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`107
`
`Fig. 5. A: Angiographic appearance of SVG at the start of case. B: Guideliner catheter (Hori-
`zontal arrow) used to increase backup support to enable proximal stent delivery (Vertical
`arrow). C: Guideliner (Horizontal arrow) used to deeply intubate SVG. D: Deployment of distal
`Promus stent (Horizontal arrow). The position of Guideliner catheter is illustrated by oblique
`arrow. E: Final result.
`
`Case 4
`
`A 64-year-old male with Re-do CABG and aortic
`and mitral valve replacement was admitted for elective
`PCI due to significant limiting angina to an OM1 graft
`with two proximal hair pin loops with a severe lesion
`at the apex of the first loop and a more distal lesion at
`the distal end of the graft with further disease within
`the native vessel (Fig. 5A). We proceeded from the left
`radial artery using an AL-1 guide. The graft was wired
`using a whisper wire, however due to the severe tortu-
`osity of the graft we were unable to deliver a balloon
`
`for predilation. The Guideliner catheter was therefore
`advanced into the asending limb of the hair pin loop to
`increase backup support and a 3-mm balloon was
`passed relatively easily into the lesion to allow predila-
`
`tion. The proximal lesion was stented with a 3.5  8
`mm Promus stent (Fig. 5B) overlapping with a 3  15
`
`mm Promus stent. Because of severe tortuosity and the
`proximally deployed stents, we were unable to pass
`further stents/balloons distally to treat the vein graft/
`native vessel disease. The Guideliner catheter was
`therefore used to bypass this area of extreme tortuosity
`
`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
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`108
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`Mamas et al.
`
`with the previously deployed stents achieving extra
`deep intubation of the vein graft (7 cm) allowing distal
`balloon/stent delivery (Fig. 5C). The distal vein graft
`
`lesion was predilated and stented using a 2.75  23
`mm Promus stent proximally (Fig. 5D) and a 2.25 
`
`23 mm stent distally into the native vessel. The stents
`were post dilated at high pressure and an excellent
`angiographic result was obtained (Fig. 5E). The patient
`remains angina free at one-month follow up.
`A further 10 cases were performed (total of 13
`cases) and these are summarized in Table I. All cases
`were performed via the radial route using conventional
`6F guiding catheters.
`
`DISCUSSION
`
`To the best of our knowledge, for the first time in the
`literature we report the successful use of the Guideliner
`catheter for distal stent delivery in a series of 13 highly
`complex cases, with a mean stent length of more than
`44 mm (range, 15–105 mm) and either severe tortuosity
`and/or calcification, or chronic occlusion in every case.
`The Guideliner catheter was used for stent delivery fol-
`lowing prior failure using conventional techniques or
`upfront use due to anticipated failure (cases 9 and 10).
`Balloon and stent delivery was successfully achieved in
`all cases and the device was simple both to deploy and
`remove and was not associated with a procedural com-
`plication in any case. This was achieved using the
`Guideliner catheter by both increasing backup support
`and crossing proximal points of obstruction. The cathe-
`ter can cross points of proximal obstruction where a
`stent gets stuck due to the greater flexibility and
`smoother surface of the catheter than a stent. In addi-
`tion, distal balloon anchoring to deliver the Guideliner
`is more readily achieved than distal balloon anchoring
`to deliver a stent within a 6F guiding catheter. The main
`limitation of the device that we have observed was stent
`damage due to trauma entering the catheter portion of
`the device at the metal collar occurring in two cases
`(two of the 32 stents delivered; 6.2%) and failure to
`pass a 4-mm stent due to resistance at this point in 1
`case (1 stent out of 32; 3.1%).
`In most cases the Guideliner catheter was advanced
`over a coronary wire into the distal vessel. In some
`cases, additional techniques were used to aid Guide-
`liner and then stent delivery in this series. In cases 2
`and 3 advancement of the Guideliner catheter was
`associated with initial resistance. This was overcome
`by anchoring a balloon catheter in the distal vessel by
`inflating it within a distal
`target
`lesion followed by
`with gentle traction on the balloon during advancement
`of the Guideliner catheter (anchor balloon technique).
`In case 2, a severe proximal stenosis that had been pre-
`
`dilated could not be crossed with a stent but was
`crossed with the Guideliner catheter enabling a stent to
`be delivered distal to the lesion within the catheter and
`then drawn back proximally into the lesion. In this
`case, crossing of the lesion with the Guideliner catheter
`was possible due to a good result from predilation;
`failure to cross the lesion directly with a stent was due
`to calcification and tortuousity at
`the lesion site. In
`cases 2, 3, 4, and 13 severe distal disease was stented
`following stenting of severe proximal disease. As well
`as facilitating proximal stenting in several of these
`cases, the Guideliner was deeply intubated through the
`stented proximal disease to gain direct access to the
`distal vessel to facilitate stenting of the distal disease.
`Anchor balloon techniques using a conventional
`guide catheter have been used to facilitate stent deliv-
`ery as well as wire and balloon passage in CTO lesions
`[7]. These techniques include both sidebranch anchor
`and distal main vessel anchor techniques. Whilst suc-
`cessful, these techniques usually require use of a 7F or
`larger guide, as smaller guides will not accommodate a
`stent with a conventional balloon catheter already in
`place. Placing the stent
`in the proximal vessel first
`could overcome this but would be technically demand-
`ing. This limits the applicability of these techniques to
`radial access when a 6F guide will be used in most
`cases. Conversely, using a distal anchor balloon to
`deliver the Guideliner catheter can easily be performed
`using a 6F guide. We have previously described this
`technique to aid delivery of the Heartrail 5-in-6 cathe-
`ter [4]. We have always deployed the anchor balloon
`at a distal lesion site that we intend to stent, both to
`help to lock the balloon more successfully and to avoid
`trauma to an undiseased coronary segment.
`to
`Conventional stenting is performed from distal
`proximal vessel in most cases, mainly due to the poten-
`tial difficulty of crossing a deployed stent in the proxi-
`mal vessel in the setting of vessel tortuousity. How-
`ever, use of the Guideliner catheter overcomes this
`restriction because of the ease with which the Guide-
`liner catheter will pass through even very tortuous
`stented segments (in some cases aided by a distal bal-
`loon anchor). In the four cases using this technique in
`this series, passage of the Guideliner catheter into the
`distal vessel through stented proximal disease was per-
`formed without complication and greatly facilitated
`distal stent delivery. We believe this technique of prox-
`imal to distal stenting using the Guideliner catheter is
`an important new technique in the setting of highly
`complex proximal and distal disease.
`In the treatment of tortuous and calcified disease it is
`failure to deliver a stent to the target lesion that remains
`one of the major causes of procedural failure. Improve-
`ments in stent design over time have been matched by
`
`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
`Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
`
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`Stent Delivery Guideliner Catheter
`
`109
`
`428mmBiomatrixwouldnotenter
`
`2.528NoboriDamaged
`
`423BiomatrixDamaged
`
`todeliverstent
`
`Stentdamage/Failure
`
`3.518Promus
`3.038Xience
`3.538Xience
`3.015Promus
`3.520Promus
`3.528Nobori
`2.5/3.519Tryton
`2.7528Promus
`2.7528Promus
`3.016Promus
`3.520Promus
`3.515mmPromus
`3.533Xience
`328Nobori
`2.528Nobori
`328Promus
`2.528Promus
`3.58Promus
`328Promus
`2.2523Promus
`328Promus
`2.518Promus
`2.518Biomatrix
`2.518Biomatrix
`3.024Biomatrix
`2.5/3.519Tryton
`4.018Biomatrix
`328Promus
`2.538Xience
`
`(lengthsinmm)
`Stentsdeployed
`
`Crossobstruction
`
`CTOcase
`
`8cm
`
`3cm
`10cm
`
`3cm
`10cm
`4cm
`
`6cm
`
`6cm
`
`3cm
`
`7cm
`
`Stentdelivery
`
`Backup
`
`Crossobstruction
`
`Stentdelivery
`Stentdelivery
`
`Stentdelivery(anticipated)
`Stentdelivery(anticipated)
`
`Stentdelivery
`
`Backup
`Backup
`
`Backup
`Backup
`Backup
`
`Stentdelivery
`
`Backup
`
`Crossobstruction
`
`Stentdelivery
`
`Stentdelivery
`
`Crossobstruction
`
`Backup
`
`Backup
`
`Crossobstruction
`
`Stentdelivery
`
`Backup
`
`6cm
`
`Stentdelivery
`
`Backup
`
`Crossobstruction
`
`Tortuous
`
`calcified
`Tortuous
`
`6cm
`
`Stentdelivery
`
`Backup
`
`Tortuouscalcified
`
`Crossobstruction
`
`3cm
`
`Balloonandstentdelivery
`
`Backup
`
`depth(cm)
`Intubation
`
`Indication
`
`Mechanism
`
`CTOlesion
`
`Obstruction
`
`Tortuouscalcified
`
`RCA
`
`Radial
`
`Tortuouscalcified
`
`Cx
`PLV
`
`LAD
`
`LeftPDA
`
`Tortuouscalcified
`
`OM
`
`Radial
`Radial
`
`Radial
`Radial
`Radial
`
`Tortuouscalcified
`
`RCA
`
`Radial
`
`Tortuouscalcified
`
`RCA
`
`Radial
`
`Tortuouscalcified
`
`LAD
`
`Radial
`
`Extremetortuousity
`
`OMVG
`
`Radial
`
`55
`
`72
`60
`
`76
`74
`71
`
`50
`
`87
`
`61
`
`64
`
`Tortuouscalcified
`
`RCA
`
`Radial
`
`76
`
`RCA
`
`LAD
`
`Radial
`
`Radial
`
`79
`
`43
`
`13
`
`12
`11
`
`10
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
`Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
`
`Vessel
`
`CaseAgeAccessSite
`
`TABLEI.SummaryofCasesPerformedUsingGuidelinerCatheter
`
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`110
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`Mamas et al.
`
`increasing case complexity. Failure to deliver a stent
`occurs in up to 5% of cases in contemporary PCI prac-
`tice [1,2] and is associated with in-hospital MACE rates
`of up to 19% [8]. Conventional techniques previously
`described to overcome problems of stent delivery
`include use of buddy wires and support wires to reduce
`tortuosity [9,10], use of rotational atherectemy or bal-
`loon dilation in calcified vessels to reduce friction [11],
`use of smaller sized stents [12] or increased backup
`support by deep intubation of the guide catheter, use of
`the anchor balloon techniques or exchange to a larger
`sized guide catheter [7]. In this series, stent delivery
`had failed in cases 1 to 8 and cases 11–13 despite pre-
`dilation and the use of either support or buddy wires.
`We have demonstrated that successful stent delivery
`using the Heartrail catheter may be achieved in up to
`90% of cases in which stent delivery had failed using
`conventional techniques [4]. More recently others have
`also adapted the Proxis proximal embolic protection
`catheter to facilitate distal stent delivery by deep intu-
`bation [13]. In the former series stent delivery was
`achieved in all cases when intubation depth of the
`Heartrail catheter exceeded 2 cm. However, stent deliv-
`ery into very proximal lesions was not successful due
`to failure to intubate the device sufficiently. In this se-
`ries, intubation depth exceeded 2 cm in all cases, and
`stent delivery was achieved in all cases.
`Large bore guides provide greater passive backup
`support and permit a greater range of interventional
`techniques [7]. However, these may be poorly tolerated
`via the radial artery. For example, in a study of 250
`patients, Saito et al. [14] demonstrated that the radial
`artery diameter was smaller than the outer diameter of
`a 7F Terumo (Terumo Co, Tokyo, Japan) introducer
`sheath in 28.5% of males and 59.7% of females. This
`may therefore contribute to procedural failure in com-
`plex cases performed through the transradial route, for
`example in a recent series of 2100 transradial PCI pro-
`cedures, 36% of procedural failures were due to inad-
`equate guide catheter support [15]. Use of Sheathless
`guide catheters may in part address this problem in the
`future
`[16]
`although their use
`is not
`currently
`widespread and they are still an evolving technology
`[17].
`All of our cases were performed successfully despite
`highly complex disease via the radial artery using 6F
`guides with back-up support augmented using deep
`intubation of the Guideliner catheter. Deep intubation
`using such a system increases backup support dramati-
`cally. Using an arterial model Takahashi et al. [5] dem-
`onstrated that 5mm of intubation using a Heartrail
`catheter within a 6F guide produced 20% greater
`backup support than a 7 Fr guide catheter and 20-mm
`intubation produced greater back-up support approach-
`
`ing that of an 8Fr guide catheter. In this series, the
`mean intubation depth was 57.7 mm (range, 30–100
`mm) therefore the additional support provided by the
`Guideliner catheter is likely to have been substantial.
`Consequently in transradial cases in which backup sup-
`port is likely to be important such as CTO cases, or
`during cases where backup support is inadequate, the
`Guideliner catheter can be used upfront or as a bale
`out device. Backup support may be particularly poor
`using conventional guiding catheters for the treatment
`of vein graft lesions [15]. Backup using a Guideliner
`catheter to achieve deep graft intubation, as in case 4,
`may therefore be very useful also in transradial vein
`graft PCI.
`The Guideliner was developed with stent delivery in
`mind and is able to deliver stents with similar effective-
`ness to the Heartrail catheter, although is easier to use
`but associated with a small but significant risk of stent
`damage. Advantages of
`the Guideliner
`include not
`needing to remove and reconnect the Y connector, less
`risk of air embolism, easier control of the mother cathe-
`ter, easier advancement and removal, and ability to
`advance a stent further distal beyond the catheter tip.
`
`Limitations of the Technique
`
`Stent damage occurred in a total of two out of 32
`stents used (6.3%) within the 6F mother guides. This
`occurred exclusively with the use of the bulkier Nobori
`(1/4 stents used) or Biomatrix stents (1/6 stents used)
`rather than lower profile Xience/Promus stents (0/20
`stents used). It was also related to stent size with fail-
`ure to pass 2/3 4 mm or larger Biomatrix or Nobori
`stents. In some cases it was clear that guide wire wrap
`around the Guideliner stainless steel introducer shaft
`had caused the stent to catch at the collar resulting in
`significant resistance to stent passage and damage.
`
`CONCLUSION
`
`The Guideliner is an easy to use guide catheter
`extension that greatly facilitates backup support and
`stent delivery, significantly extending the scope of cor-
`onary intervention possible within a 6F mother guide
`catheter. It should be considered either to increase
`backup support or enable stent delivery when problems
`are encountered using conventional
`techniques, or
`upfront in the setting of very complex disease. Per-
`formance is similar to the 5-in-6 Heartrail II catheter,
`whilst ease of use is significantly improved. The main
`limitation however is that there is a small risk that
`large/bulky stents can get damaged entering the metal
`collar, and caution should be exercised particularly
`when resistance to the passage of a stent is felt whilst
`
`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
`Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
`
`
`Page 9
`
`Teleflex Ex. 2179
`Medtronic v. Teleflex
`
`

`

`within the Guideliner catheter since excess force may
`not only lead to damage of the stent but also to poten-
`tial stent loss. We would currently recommend the use
`of low profile stents with this system since this appears
`to limit the potential for stent damage in our series and
`would caution the Guideliner
`for stent delivery of
`
`stents 4 mm in diameter. Future catheter design mod-
`
`ifications, particularly at the steel collar may reduce
`the small risk of stent damage that we have observed.
`This device will be useful for both transfemoral and
`transradial procedures in which backup support and
`stent delivery difficulties are encountered, and may be
`of especial interest to radial interventionalists taking on
`complex disease. Early or upfront use in highly com-
`plex cases should be considered.
`
`REFERENCES
`
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`ter support. Catheter Cardiovasc Interv 2008;72:505–512.
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`ing to facilitate stent advancement across a highly calcified ar-
`tery. Catheter Cardiovasc Interv 2006;67:721–723.
`10. Vijayvergiya R, Swamy AJ, Grover A. Buddy wire technique:
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`neous coronary intervention: A case report. J Invasive Cardiol
`2006;18:E129–E130.
`11. Cavusoglu E, Kini AS, Marmur JD, Sharma SK. Current status
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`12. Feldman T. Tricks for overcoming difficult stent delivery. Cath-
`eter Cardiovasc Interv 1999;48:285–286.
`13. Brilakis ES, Banerjee S. Novel uses of the Proxis embolic pro-
`tection catheter. Catheter Cardiovasc Interv 2009;74:438–445.
`14. Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of the ratio
`between radial artery inner diameter and sheath outer diameter
`on radial artery flow after transradial coronary intervention.
`Catheter Cardiovasc Interv 1999;46:173–178.
`15. Dehghani P, Mohammad A, Bajaj R, Hong T, Suen CM, Shar-
`ieff W, Chisholm RJ, Kutryk MJ, Fam NP, Cheema AN. Mech-
`anism and predictors of failed transradial approach for percuta-
`neous coronary interventions. JACC Cardiovasc Interv 2009;2:
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`16. Mamas MA, Fath-Ordoubadi F, Fraser DG. Atraumatic complex
`transradial intervention using large bore sheathless guide cathe-
`ter. Catheter Cardiovasc Interv 2008;72:357–364.
`17. Mamas MA, D’Souza S, Hendry C, Ali R, Iles-Smith H, Palmer
`K, El-Omar M, Fath-Ordoubadi F, Neyses L, Fraser DG. Use of
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`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
`Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
`
`
`Page 10
`
`Teleflex Ex. 2179
`Medtronic v. Teleflex
`
`

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